3rd PEARRL Annual Meeting Model Informed Drug Development...Page 6 of 10 Day 3 – 12th June 2019...

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 674909.

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3rd PEARRL Annual Meeting

Model Informed Drug Development

10th – 14th June 2019 National and Kapodistrian University of Athens, Faculty of

Pharmacy, Greece https://www.pearrl.eu/AM2019.html

https://www.pearrl.eu/AM2019.html

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Programme of events Programme ...............................................................................................................................................................3

Detailed Agenda for Scientific Programme ...............................................................................................................4

Day 1 – 10th June 2019 – Science Slams ......................................................................................................... 4

Day 2 – 11th June 2019- Science Slams .......................................................................................................... 5

Day 3 – 12th June 2019 – Open scientific symposium on Model Informed Drug Development ..................... 6

Theme: Lead optimisation through to pre-clinical development ........................................................ 6

Day 4 – 13th June 2019 - Open scientific symposium on Model Informed Drug Development ...................... 7

Theme: Clinical development through to pharmaceutical product lifecycle management ...................... 7

Day 5 – 14th June 2019 - Transferable skills workshops ................................................................................. 8

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Programme H2020 ITN PEARRL project (no.674909) PEARRLs of Wisdom Week 2019

https://www.pearrl.eu/am2019.html Date 10th– 14th June 2019

Theme of Annual

meeting

Model Informed Drug Development

Schedule Day 1 Science Slams – ESR research presentations Day 2 Science Slams – ESR research presentations Day 3 Scientific symposium

Session I – Model informed lead optimization and pharmaceutical profiling Session II: Model informed pre-clinical development

Day 4 Scientific symposium Session III: Model informed Clinical Pharmaceutical Development Session IV: Emerging trends in pharmaceutical product lifecycle management

Day 5 Transferable & career skills workshop

Networking events Sunday Pre-Conference Get-Together (PIs and ESRs) Day 1 Informal networking Day 2 PIs dinner / ESRs visit to the Acropolis museum / ESRs dinner Day 3 PIs/Speakers/ESRs dinner Day 4 Informal networking Day 5 ESRs visit at Sounion

Location Athens, Greece

Address

National and Kapodistrian University of Athens, Main Building, Panepistimiou 30,

10679 Athens

Wi-fi access Username & Password will be provided during the meeting

https://www.pearrl.eu/am2019.html

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Detailed Agenda for Scientific Programme

Day 1 – 10th June 2019 – Science Slams Theme: Science & Technology

Attendees: PEARRL Beneficiaries

Time Session Speaker Session Title

9:00 – 11:00 ESR presentations (WP1)

ESR1 – Niklas Köhl ESR2 – Felix Ditzinger ESR3 – Daniel Price

ESR presentations

11:00-11:15 Coffee

11:15-13:15 ESR presentations (WP1)

ESR4 – Georgia Tsakiridou ESR5 – Sandra Jancovic ESR14 –Roxana Ilie

ESR presentations

13:15-14:00 Lunch

14:00 – 16:00

ESR presentations (WP2)

ESR7 – Christina Pentafragka ESR9 – Laura Henze ESR10 – Patrick O’Dwyer

ESR presentations

16:15-16:30 Coffee

16:30 – 17:45

ESR presentations (WP2)

ESR11 – Marina Statelova ESR13 – Ioannis Loisios-Konstantinidis

ESR presentations

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Day 2 – 11th June 2019- Science Slams Theme: Science & Technology

Attendees: PEARRL Beneficiaries

Time Session Speaker Session Title

9:00 – 11:00 ESR presentations (WP3)

ESR6 – Chara Litou ESR8 – Raphael Paraiso ESR12 – Mariana Guimarães

ESR presentations

11:00-11:15 Coffee

11:15-12:00 ESR presentations (WP3)

ESR15 – Angela Effinger ESR presentations

12:00-13:00 WP1,2 & 3 wrap up and planning

All

13:00-14:00 Lunch 14:00-15:00

Management Management Board (PMB)

Project Management, Deliverables and

Milestones,

Discuss the status of publications and score

cards and finalize format / contents (e.g.

commentaries? E.g. for WP2 could be in vivo

vs. in vitro tools for evaluating absorption?)

Discuss the webinar for March 2020

15:00-16:00

Supervisory Board (PSB) Meeting/Webinar Project status, WP info, Training Programme, FAQ

16:00-17:00

Scientific Advisory Board (SAB)

Meeting/Webinar Project overview, WPs1-3, FAQ

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Day 3 – 12th June 2019 – Open scientific symposium on Model Informed Drug

Development

Theme: Lead optimisation through to pre-clinical development

Attendees: PEARRL Beneficiaries, Partners and External invites

Time Topic Speaker Presentation Title

08:30 Registration

08:45 Welcome address C. Reppas/M. Vertzoni

Session I – Model informed lead optimization and pharmaceutical profiling

09:00 Drug candidate lead optimisation Martin Kuentz (FHNW, Switzerland)

Digital approaches from drug candidate selection to computational pharmaceutics

09:45 Pharmaceutical Profiling Jennifer Dressman (UGoethe, Germany)

Pharmaceutical Profiling

10:30 PEARRL approaches to predicting formulation design

Dan Price (Merck, Germany)

COSMOquick as a predictor of drug/excipient interactions in enhanced dosage forms

10:45 Coffee

11:15 High throughput biopharmaceutical screening

Jochem Alsenz, Roche,

Switzerland High throughput biopharmaceutical screening

12:00 PEARRL approaches to Biorelevant in vitro screening

Patrick O’Dwyer (Pion, UK)

A guide to small scale screening for drug-specific questions


Felix Ditzinger (UNWS, Switzerland) Georgia Tsakiridou (Pharmathen, Greece)

Solid dispersions based on a modelling rationale


Niklas Koehl (UCC, Ireland) Roxana Ilie (J&J, Belgium)

A guide to bioenabling formulation selection in development: focus on lipid based approaches

13:15 Lunch

Session II – Model informed pre-clinical development

14:15 Role of rDCS in guiding preclinical pharm development

James Butler (GSK, UK) Role of rDCS in guiding preclinical pharm development

15:00 Role of PBPK in guiding preclinical pharm development

Christian Wagner (Merck, Germany)

Role of PBPK in guiding preclinical pharm development

15:45 Coffee

16:15 Role of animal modelling in preclinical pharm development

Sandy Van Hemelryck (J&J, Belgium)

Preclinical Bioavailability Strategy for Decisions on Clinical Drug Formulation Development

17:00 PEARRL approaches to biorelevant in vitro screening

Chara Litou (UGoethe, Germany)

The role of biorelevant testing in formulation development

17:15 PEARRL approaches to biorelevant in vitro screening

Christina Pentafragka (UoA, Greece)

Using luminal data for modelling absorption in the fed state

17:30 End of Day 1

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Day 4 – 13th June 2019 - Open scientific symposium on Model Informed Drug

Development

Theme: Clinical development through to pharmaceutical product lifecycle management

Attendees: PEARRL Beneficiaries, Partners and External invites

Time Session/Topic Speaker Presentation Title

Session III – Model informed clinical development

09:00 Formulation for first in man studies

James Butler (GSK, UK) Formulation for first in man studies

09:45 Transitioning to the final formulation. What are the challenges?

Bertil Abrahamsson (AZ, Sweden)

Transitioning to the final formulation. What are the challenges?

10:30 Coffee

11:00 PBPK modelling of food effects Neil Parrott (Roche, Switzerland)

PBPK modelling of food effects

11:45 PBPK modeling of DDIs Masoud Jamei (Certara, UK)

Applications of PBPK modelling in predicting complex DDIs

12:30

PEARRL approaches to

predicting in vivo outcomes

using in silico tools

Angela Effinger (Bath, UK)

Targeting GI diseases

12:45 PEARRL approaches to

biorelevant in vitro screening

Mariana Guimaraes

(UBath, UK)

In vitro evaluation of drugs/drug

products for paediatrics

13:00

PEARRL approaches to

predicting in vivo outcomes

using in silico tools

Marina Statelova

(UoA, Greece) In silico evaluation of drugs/drug

products for paediatrics

13:15 Lunch

Session IV – Emerging trends in pharmaceutical product lifecycle management

14:00 Developing generic products Lida Kalantzi

(Pharmathen, Greece) Developing generic products

14:45 Clinically relevant dissolution testing

Sandra Suarez (FDA, USA)

Tbd.

15:30 Coffee

16:00 Continuous manufacturing Frank Stieneker

Future Manufacturing of Drug Products: the Impact of Single Piece Flow, Pull Production and Parametric Process Control


(Sandra Jankovic (UNWS, Switzerland)

Emerging process analysers in pharmaceutics

17:00 PEARRL approaches to predicting in vivo outcomes using in silico tools

Ioannis Loisios (UGoethe, Germany)

Establishing virtual bioequivalence trials simulation using population-based PBPK modelling

17:15 PEARRL approaches to predicting in vivo outcomes using in silico tools

Raphael Paraiso (UGoethe, Germany)

The role of in vitro and in silico tools to support bioequivalence studies

17:30 End of Day 2

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Day 5 – 14th June 2019 - Transferable skills workshops Theme: Generic and Transferable skills training

Attendees - ESRs

Time Session Speaker Title

9:00 Innovation in the pharmaceutical industry

Mark McAllister, Pfizer

Leveraging S&T for innovative product and process design

10:00 Managing Intellectual property for commercial success

Apostolos Aivaliotis (IP Senior Manager, Pharmathen)

Patent related topic tbd.

11:00 Entrepreneurship and commercial start up for pharma

Daryl Leigh (Biorelevant.com Ltd.)

Entrepreneurship and commercial start up for pharma

12:00 Project management and getting the grant/sales pitch right!

Jeanette Muller (accelopment AG)

Tbd.

13:00 Lunch

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Invited Speakers (Provisional list)

Dr. Bertil Abrahamsson AstraZeneca R&D Mölndal, Sweden

Apostolis Aivaliotis Pharmathen S.A. Marousi Attica, Greece

Dr. Jochem Alsenz F. Hoffmann- La Roche Ltd.Basel, Switzerland

Dr. James Butler GlaxoSmithKline Ware, UK

Sandy Van Hemelryck Janssen Pharmaceutica Belgium

Dr. Masoud Jamei Certara United Kingdom

Dr. Lida Kalantzi Pharmathen S.A. Marousi Attica, Greece

Daryl Leigh Biorelevant.com Ltd. United Kingdom

Dr. Mark McAllister Pfizer PGRD Sandwich, Kent, UK

Neil John Parrott F. Hoffmann- La Roche Ltd., Basel, CH

Dr. Frank Stieneker

Dr. Sandra Suarez The Food and Drug Administration (FDA), USA

Dr. Christian Wagner Merck Group Darmstadt, Germany

Felix Ditzinger Early Stage Researcher (ESR2), University of Applied Sciences & Arts Northwestern Switzerland

Angela Effinger Early Stage Researcher (ESR15) University of Bath, School of Pharmacy United Kingdom

Alexandra-Roxana Ilie Early Stage Researcher (ESR14) Janssen Pharmaceutical N.V., Belgium

https://www.pearrl.eu/uploads/7/0/9/9/70997359/pearrl-cv-abrahamsson.pdfhttps://www.pearrl.eu/uploads/7/0/9/9/70997359/pearrl-cv-butler.pdfhttps://www.pearrl.eu/uploads/7/0/9/9/70997359/pearrl-cv-van_hemelryck.pdfhttps://www.pearrl.eu/uploads/7/0/9/9/70997359/pearrl-cv-jamei.pdfhttps://www.pearrl.eu/dr-l-kalantzi.htmlhttps://www.pearrl.eu/uploads/7/0/9/9/70997359/pearrl-cv-mcallister.pdfhttps://www.pearrl.eu/uploads/7/0/9/9/70997359/pearrl-cv-wagner.pdfhttps://www.pearrl.eu/esr2.htmlhttps://www.pearrl.eu/esr15.htmlhttps://www.pearrl.eu/esr14.html

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Mariana Guimarães Early Stage Researcher (ESR12) University of Bath, School of Pharmacy United Kindgom

Sandra Jankovic Early Stage Researcher (ESR5) University of Applied Sciences & Arts Northwestern Switzerland

Niklas Köhl Early Stage Researcher (ESR1) University College Cork, School of Pharmacy Ireland

Chara Litou Early Stage Researcher (ESR6) Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology, Germany

Ioannis Loisios-Konstantinidis Early Stage Researcher (ESR13) Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology, Germany

Patrick O'Dwyer Early Stage Researcher (ESR10) Pion Inc. (UK) Ltd. United Kingdom

Rafael Leal Monteiro Paraiso Early Stage Researcher (ESR8) Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology, Germany

Christina Pentafragka Early Stage Researcher (ESR7) National and Kapodistrian University of Athens, Faculty of Pharmacy Greece

Daniel Price Early Stage Researcher (ESR3) Merck Group, Molecule Characterisation Germany

Marina Statelova Early Stage Researcher (ESR11) National and Kapodistrian University of Athens, Faculty of Pharmacy Greece

Georgia Tsakiridou Early Stage Researcher (ESR4) Pharmathen SA, Product Design & Evaluation Greece
https://www.pearrl.eu/esr12.htmlhttps://www.pearrl.eu/esr5.htmlhttps://www.pearrl.eu/esr1.htmlhttps://www.pearrl.eu/esr6.htmlhttps://www.pearrl.eu/esr13.htmlhttps://www.pearrl.eu/esr13.htmlhttps://www.pearrl.eu/esr10.htmlhttps://www.pearrl.eu/esr8.htmlhttps://www.pearrl.eu/esr8.htmlhttps://www.pearrl.eu/esr7.htmlhttps://www.pearrl.eu/esr3.htmlhttps://www.pearrl.eu/esr11.htmlhttp://en.pharm.uoa.gr/http://en.pharm.uoa.gr/http://en.pharm.uoa.gr/https://www.pearrl.eu/esr4.htmlhttp://www.pharmathen.com/home/home-27.htm?lang=en

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